Fluid handling device and method of making same

ABSTRACT

A fluid handling device, such as a needlefree access device, includes a housing having an inlet and an inlet channel; and a flow control member comprising a combination outlet, biasing and piston member. The flow control member includes a piston section moveable between a closed position in which the piston section is inside the housing below the inlet channel but allows fluid to flow through the inlet channel; a biasing section connected to the piston section that normally biases the piston section into the inlet channel; and an outlet section connected to the biasing section having an outlet fitting in fluid communication with the inside of the housing.

RELATED APPLICATIONS

The present application claims the benefit under 35 U.S.C. § 119(e) ofProvisional U.S. Patent Application Ser. No. 60/479,403, filed Jun. 17,2003; which is hereby incorporated by reference in its entirety.

BACKGROUND

This invention relates to fluid handling devices, particularly formedical purposes, and methods of making fluid handling devices. Theinvention is particularly suitable for needlefree access devices andcheck valves.

The use of hypodermic needles to inject or withdraw fluids in medicalapplication had been standard practice up until a few years ago. Evenwhere a patient already had an IV tubing set connected to a vein,hypodermic needles were frequently used to inject fluids into the IVtubing. Often a “Y” access device with a septum was provided in thetubing set for this very purpose. The needle was used to puncture theseptum to administer the drug or other fluid, and the septum thensufficiently sealed the opening to prevent leakage, and prevent airbornebacteria from entering the system. Septums are also common on drugvials, where the needle is inserted to withdraw a quantity of the drug.

The widespread use of hypodermic needles lead to numerous needle-stickaccidents. These were not only painful, but if the needle iscontaminated, could cause serious disease or complications in theneedle-stick victim. There has been a desire for needlefree medicalsystems, where a fluid can be injected or aspirated without the use of aneedle, but while maintaining an aseptic leak-free system.

Numerous devices have been developed to achieve this goal. Many of thosedevices have been disclosed in the patent literature. One early suchdevice is disclosed in U.S. Pat. No. 5,360,413. The differentembodiments of the needleless access device disclosed in the '413 patenthave proven to be influential in the design of subsequent needlefreeaccess devices. Many of the concepts have been used in other devices.The wiper seal to seal the inlet channel against airborne bacteria andthe piston head that can be easily swabbed prior to actuation are two ofthe more significant features.

Even with all the work and development that has transpired over theyears in this area, there is still need for improvement, particularlywith respect to better performance, such as greater flow rate andreduced trapped drug and fluid after flushing, and lower cost. Thepreferred embodiments disclosed in the '413 patent are assembled fromfour or five components, depending on the design. Even though the partscan be mass produced, the product cost is dependent on the number ofindividual components that have to be made, and then assembled. Mostneedlefree access devices commonly available contain at least threeparts. Many prior needlefree access devices also have internalconfigurations that allow fluid to be trapped in the device even afterflushing. Also, many prior devices are fairly large and therefore have ahigher material cost and internal volume.

Check valves are also often assembled from three or more parts. Forexample, U.S. Pat. No. 5,771,935 and No. 4,749,003 both disclose checkvalves that are assembled from three separate components. The cost ofsuch products could be reduced if they were assembled from only twoparts.

The desire to reduce the number of parts that must be assembled,however, cannot override the more important fact that the fluid handlingproducts must meet several critical design features. Thus, there is areal need for fluid handling products that can be made at a lower cost,but still meet the end user's specifications. Also, there is a need forfluid handling products that have reduced hold up-volumes, are easier toprime and flush, and that have a flow path through the device that isvisible to the user so that any bubbles can be spotted and the flow ofsolutions can be visualized.

BRIEF SUMMARY

The present invention includes fluid handling devices, such asneedlefree access devices and check valves, that are lower in cost andhave low hold-up volumes. Preferred fluid handling devices may beassembled from only two parts, yet still provide at least as good, andin many ways superior, performance compared to many prior art devices.The present invention also includes check valves that may be assembledfrom only two parts. Methods of making fluid handling devices by atwo-shot molding process have reduced labor cost and improved qualitycontrol.

In a first aspect, the invention is a fluid handling device having ahousing, a sealing surface and a flow control member comprising aflexible material biased against said sealing surface, characterized inthat the flow control member is overmolded onto a constructive member ofthe fluid handling device such that they can be handled as one unit whenbeing assembled with the housing to produce the fluid handling device.

In a second aspect, the invention is a fluid handling device comprisinga housing having an inlet and an outlet and comprising a first housingpart and a second housing part; a sealing surface inside the housing;and a sealing member comprising a flexible material biased against thesealing surface; wherein the first and second housing parts are producedfrom thermoplastic material, and the sealing member and the secondhousing part are molded together such that they can be handled as oneunit when being assembled with the first housing part to produce thefluid handling device.

In a third aspect, the invention is a method of making a fluid handlingdevice comprising forming a first housing part from a thermoplasticmaterial, the first housing part having a sealing surface; forming asecond housing part from a thermoplastic material; forming a sealingmember comprising a flexible material by overmolding the sealing memberto the second housing part such that the second housing member andsealing member can be handled as one unit when being assembled with thefirst housing part; and connecting the first housing member and secondhousing member together, with the sealing member biased against thesealing surface, to form the fluid handling device.

In another aspect, the invention is a needlefree access devicecomprising a housing having an inlet and an inlet channel; and acombination outlet, biasing and piston member having a piston sectionmoveable between a closed position in which the piston section is in theinlet channel and an open position in which the piston section is insidethe housing below the inlet channel but allows fluid to flow through theinlet channel, a biasing section connected to the piston section thatnormally biases the piston section into the inlet channel; and an outletsection interlocked to the biasing section and having an outlet fittingin fluid communication with the inside of the housing, wherein thepiston section, biasing section and outlet section are connectedtogether such that they can be handled as one piece when assembled withthe housing to make the needlefree access device.

In an additional aspect, the invention is a fluid handling devicecomprising a housing and a flow control member, the flow control membercomprising thermoplastic material and thermosetting material overmoldedto the thermoplastic material.

In a further aspect, the invention is a needlefree access devicecomprising: a housing and a flow control member, the flow control membercomprising a thermoplastic outlet section and a resilient materialovermolded onto the thermoplastic material.

In still another aspect, the invention is a flow control member for usein a needlefree access device, the flow control member comprising anoutlet section formed of thermoplastic material; and a combined biasingsection and piston section formed from resilient material, the biasingsection being molded onto the outlet section.

In a still further aspect, the invention is a needlefree access devicecomprising a housing having an inlet, a base, and a main body portionhaving a generally cylindrical inside surface between the inlet and thebase; a valve member actuatable between an open position and a closedposition, wherein in the closed position the valve member prevents flowbetween the inlet and the outlet; a central body within the main bodyportion of the housing, the central body having a helical shape on itsouter surface, the central body fitting against the inside of thecylindrical surface when the valve member is in its open position; thehelical shape thus defining a helical flow path through the main bodyportion of the housing when the valve member is in an open position.

In an additional aspect, the invention is a needlefree access devicecomprising a housing having a round inlet, a tapered inlet channel thatnarrows inwardly from the inlet, a main body portion, and a baseopposite the inlet; a piston member inside the housing; and a biasingmember inside the housing normally biasing the piston member to closethe inlet; wherein the piston member comprises a resilient material witha top having a generally elliptical shape and an opening that is closedwhen the top of the piston is forced into the round inlet opening butwhich allows flow through the opening to the outside of the pistonmember when the piston member is forced downwardly against the biasingforce and out of the tapered inlet channel.

In a still further aspect, the invention is a method of making aneedlefree access device comprising forming a housing having an inletand a base; forming a flow control member by molding thermoplasticmaterial to form an outlet member and molding resilient material ontothe outlet member, the resilient material forming a piston section and abiasing section; inserting the flow control member into the housing suchthat the piston section is adjacent to the inlet; and securing theoutlet member into the base of the housing.

In another aspect, the invention is a method of making a needlefreeaccess device comprising providing a first part comprising amonolithically formed housing; providing a second part comprising acombination outlet section, biasing section and piston section;constructing the needlefree access device by securing the second partwithin the first part, the access device being made only from the firstand second parts.

In a still further aspect, the invention is a needlefree access devicecomprising a housing having an inlet, an inlet channel and an outlet;and a biasing and piston member having a piston section moveable betweena closed position in which the piston section is in the inlet channeland an open position in which the piston section is inside the housingbelow the inlet channel but allows fluid to flow through the inletchannel; and a biasing section connected to the piston section thatnormally biases the piston section into the inlet channel, the biasingsection comprising a resilient body having a helical shape on at leastpart of its outer surface.

The preferred needlefree access device, being made with only two parts,can be assembled at a low cost. By using a two-shot molding process, acombination part can be made that includes several functional sections:a piston section, a biasing section and an outlet section. The uniquemanufacturing methods of the present invention allow this part to bemade at a relatively low cost, yet the preferred needlefree accessdevice has functional characteristics that are highly desirable. Inaddition, quality control is improved since only two parts have to beassembled. These and other advantages and features of the invention willbe best understood in light of the attached drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a first embodiment of a needlefreeaccess device of the present invention;

FIG. 2 is a view of the access device of FIG. 1 from a differentperspective;

FIG. 3 is an exploded view of the combination outlet, biasing and pistonmember, also referred to as a flow control member, of the access deviceof FIG. 1;

FIG. 4 is an exploded perspective view of the access device of FIG. 1;

FIG. 5 is a longitudinal cross-sectional view of the housing used in theaccess device of FIG. 1;

FIG. 6 is a cross-sectional view taken along line 6-6 of FIG. 4;

FIG. 7 is a cross-sectional view taken along line 7-7 of FIG. 1;

FIG. 8 is a partial cross-sectional view taken along line 8-8 of FIG. 1;

FIG. 8A is a partial cross-sectional view of the access device of FIG. 1shown in its open, activated position;

FIG. 9 is a perspective view of a second embodiment of combined biasingand piston sections of a flow control member of the present invention;

FIG. 10 is a cross-sectional view of a third embodiment of a needlefreeaccess device of the present invention in its open, activated position;

FIG. 11 is a cross-sectional view of a fourth embodiment of a needlefreeaccess device of the present invention;

FIG. 11A is a cross-sectional view taken along line 11A-11A FIG. 11;

FIG. 12 is a cross-sectional view of a fifth embodiment of a needlefreeaccess device of the present invention;

FIG. 13 is a cross-sectional view of a sixth embodiment of a needlefreeaccess device of the present invention;

FIG. 14 is a partial cross-sectional view of an I.V. bag using theneedlefree access device of FIG. 1 as a bag port;

FIG. 15 is a cross-sectional view of a seventh embodiment of a flowcontrol member of the present invention;

FIG. 16 is a cross-sectional view of an eighth embodiment of a flowcontrol member of the present invention;

FIG. 17 is a cross-sectional view of a ninth embodiment of a flowcontrol member of the present invention;

FIG. 18 is a cross-sectional view of a tenth embodiment of a flowcontrol member of the present invention;

FIG. 19 is a cross-sectional view of an eleventh embodiment of a flowcontrol member of the present invention;

FIG. 20 is a cross-sectional view of a twelfth embodiment of a flowcontrol member of the present invention;

FIG. 21 is a cross-sectional view of a thirteenth embodiment of aneedlefree access device of the present invention;

FIG. 22 is a cross-sectional view of the mold tool used to form theoutlet section of the access device of FIG. 1;

FIG. 23 is a cross-sectional view of the mold tool used to overmold thecombined biasing section and piston section of the access device of FIG.1;

FIG. 23A is a partial enlarged cross-sectional view of an alternateembodiment of the mold tool used to overmold an alternate combinedbiasing section and piston section of the access device of FIG. 1;

FIG. 24 is an elevational schematic view of a horizontal molding pressthat can be used to make needlefree access devices of the presentinvention;

FIG. 24A is a schematic top view of one embodiment of the operation ofthe central portion of the press of FIG. 24;

FIG. 24B is a schematic top view of a second embodiment of the operationof the central portion of the press of FIG. 24;

FIG. 24C is a schematic top view of a third embodiment of the operationof the central portion of the press of FIG. 24;

FIG. 25 is a schematic view of a manufacturing cell that can be used tomake access devices of the present invention using two vertical moldingpresses;

FIG. 26 is a perspective view of a fourteenth embodiment of combinedbiasing and piston sections of a flow control member of the presentinvention;

FIG. 27 is a cross-sectional view of a needlefree access device usingthe flow control member with the combined biasing and piston sections ofFIG. 26;

FIG. 28 is a cross-sectional view of a first Y-shape needlefree accessdevice of the present invention;

FIG. 29 is a cross-sectional view of a second Y-shape needlefree accessdevice of the present invention;

FIG. 30 is a partial cross-sectional view of a fifteenth embodiment of aneedleless access device of the present invention shown in its closedposition;

FIG. 30A is a partial cross-sectional view of the needleless accessdevice of FIG. 30 shown in its open, actuated position;

FIG. 31 is a top perspective view of the flow control member of theaccess device of FIG. 30;

FIG. 32 is a perspective view of the outlet member used in the accessdevice of FIG. 30;

FIG. 33 is a perspective view of a first alternate piston section thatcould be used in the access device of FIG. 30;

FIG. 34 is a perspective view of a second alternate piston section thatcould be used in the access device of FIG. 30;

FIG. 35 is a perspective view of a third alternate piston section thatcould be used in the access device of FIG. 30;

FIG. 36 is a partial cross-sectional view of a sixteenth embodiment of aneedleless access device of the present invention shown in its closedposition;

FIG. 37 is a perspective view of a seventeenth embodiment of combinedbiasing and piston sections of a flow control member of the presentinvention;

FIG. 38 is a perspective view of an eighteenth embodiment of combinedbiasing and piston sections of a flow control member of the presentinvention;

FIG. 39 is an exploded view of a needleless access device using amodified version of the combined biasing and piston sections of FIG. 38;

FIG. 40 is a cross-sectional view of the access device of FIG. 38 shownin its closed position;

FIG. 41 is a cross-sectional view of the access device of FIG. 38 shownin its open, activated position;

FIG. 42 is an elevational view of an nineteenth embodiment of combinedbiasing and piston sections of a flow control member of the presentinvention;

FIG. 43 is a cross-sectional view of a twentieth embodiment of aneedleless access device of the present invention shown in its closedposition;

FIGS. 44A-44F are perspective views of six alternate embodiments ofpiston sections that could be used in the access device of FIG. 30;

FIG. 45 is an opened, perspective view of two mold halves used to formthe biasing and piston sections of the flow control member used in theaccess device of FIG. 30;

FIG. 46 is a schematic representation of the operation of the mold toolsof FIG. 45 along with other mold tools used to make and assemble theaccess device shown in FIG. 30;

FIG. 47 is a cross-sectional view of a twenty-first embodiment of aneedleless access device with positive displacement of the presentinvention shown in its closed position;

FIG. 48 is a cross-sectional view of a twenty-second embodiment of aflow control member used to make a positive displacement needlelessaccess device of the present invention;

FIG. 49 is a perspective, cross-sectional view of a twenty-thirdembodiment of a needleless access device with positive displacement ofthe present invention shown in its closed position;

FIG. 50 is an exploded view of the access device of FIG. 49;

FIG. 51 is a cross-sectional view of the access device of FIG. 49 in itsopen, activated position;

FIG. 52 is a cross-sectional view of a twenty-fourth embodiment of aneedleless access device of the present invention shown in its closedposition;

FIG. 53 is a cross-sectional view of a first embodiment of a check valveof the present invention; and

FIG. 54 is a cross-sectional view of a second embodiment of a checkvalve of the present invention.

DETAILED DESCRIPTION OF THE DRAWINGS AND THE PRESENTLY PREFERREDEMBODIMENTS

As used herein, the term “fluid handling device” means a device thatallows a fluid, particularly a medical fluid, to be transferred from onelocation, through the device, to another location. The fluids can besaline solutions, solutions containing drugs or other medicaments, orbiological fluids, including blood. The fluids can be gases, especiallygases used for medical purposes.

One class of fluid handling devices are needlefree access devices, suchas luer activated valves that allow a syringe tip to be inserted intothe access device and open the valve so that a fluid can be administeredor withdrawn through the access device without a hypodermic needle. Manyother needlefree access devices are parts to IV administration systems.Of course there are needlefree access devices that will not necessarilyinclude valves, nor need to mate with standard luer access devices. Manyother fluid handling devices, such as bag ports, vial adapters,stopcocks, manifolds and the like, may be equipped with needleless lueractivated valves. Another class of fluid handling devices to which thepresent invention especially pertains is check valves.

The first preferred embodiment of a needlefree access device 10 of thepresent invention is shown in FIGS. 1-9. As noted above, the accessdevice 10 is assembled from a first part, which comprises a housing 20,and a second part 40, which comprises a combination outlet, biasing andpiston member. This second part acts as a flow control member. Togetherthe two parts 20 and 40 form the complete needlefree access device 10.As will be explained in detail, the flow control member 40 providesseveral functional parts to the access device 10. It is preferably madein a two shot molding process. Since one molding press is needed for thetwo shot molding, the cost for this part is less than if it were madefrom two separate molding operations. Furthermore, since the accessdevice 10 is made from only these two parts, it can be assembled at alower cost than if it were assembled from three or more parts.

The housing 20 is preferably monolithically formed, such as by aninjection molding process. As best seen in FIGS. 4 and 5, the housinghas a round inlet 22 leading into a tapered inlet channel 24 thatnarrows inwardly from the inlet 22. The inlet 22 and inlet channel 24preferably form a female luer taper for engaging with a syringe tip 18(FIG. 9) having a standard male luer taper. The housing also includes abase 26 with threads 36 for forming a luer lock.

The housing 20 has a main body portion 28 with a generally smoothcylindrical inside wall surface 29 between the inlet 22 and the base 26.The housing also includes an internal sealing surface 30. The outside ofthe upper portion 32 of the housing 20 also includes threads 38 for aluer lock.

The combination outlet, biasing and piston member 40 can be thought ofas having three sections: a piston section or head 50, a biasing section60 and an outlet section 70. The piston section 50 provides a pistonmember with a wiper seal 52 and a sealing member, also referred to as avalve member 54. The piston section is movable between a closedposition, in which the piston section is in the inlet channel 24 (FIG.8), and an open position, in which the piston section is inside thehousing below the inlet channel, but allows fluid to flow through theinlet channel (FIG. 8A). The wiper seal 52 is dimensioned so that itensures sealing in the inlet channel acting to maintain sterilityagainst bacterial contamination when the piston section is in its closedposition, and to wipe the inlet channel so as to leave the wiped area ina clean state. In the closed position, the valve member 54 of the pistonsection seals against the internal sealing surface 30 of the housing,thus preventing flow between the inlet and the outlet. This is primarilyused to prevent backflow through the access device when the pistonsection is in the closed position. The biasing section preferablyprovides sufficient force to keep the valve member 54 closed even if avacuum is drawn on the outlet.

The biasing section 60 is connected to the piston section 50 andnormally biases the piston section into the inlet channel 24. Thebiasing section 60 has a central hollow portion 62 (FIG. 6), whichallows the wall 64 of the biasing section 60 to collapse. The biasingsection 60 also provides a central body having a helical shape on itsouter surface, such as a helical groove 64 on the outside thereof.Otherwise, in a collapsed state, the central body fits against theinside of the cylindrical surface 29 of the housing. The helical groove64 thus defines a helical flow path or channel through the main bodyportion 28 of the housing 20. When the access device is in its openposition (FIG. 8A) the helical flow channel formed in the outer surfaceof the biasing section 60, around its center portion, preferably has across-sectional width 66 of about 0.02 inches. Preferably the biasingsection 60 and piston section 50 are formed as one monolithic piece.

The outlet section 70 is connected to the biasing section 60, preferablyby having the biasing section 60 overmolded to the outlet section. Theoutlet section provides an outlet fitting 72, preferably having a maleluer taper. The outlet fitting 72 is in fluid communication with theinside of the housing. The outlet section includes a flange 74 that fitsin a recess 37 in the housing 20 (FIG. 5). Thus, the outlet section 70forms a closure to the housing 20, thus directing flow through thehousing to pass through the outlet fitting 72. Fluid can enter theoutlet fitting through openings 76 formed near the top of the outletsection. These openings are in fluid communication with the central flowchannel 78 through the center of the outlet section 70. Preferably thehousing 20 includes an internally threaded section 35 (FIG. 5) adjacentthe connection between the biasing section and the outlet section sothat fluid traveling down the helical flow channel 64 can make it pastthe connection between the biasing section and the outlet section andinto openings 76.

The biasing section and piston section are preferable made of resilientmaterial, and more preferably a resilient thermosetting material such assilicone, whereas the outlet section is preferably made of rigidthermoplastic. In the past, these two materials have not been commonlymolded together, especially in a configuration wherein the thermosettingmaterial is formed in a shape that for the most part extends away fromthe thermoplastic component in a free-standing manner. (U.S. Pat. No.4,983,344 discloses an electrical connector where the outer body memberis made of thermoplastic and is filled with a thermosetting material,but in that connector, the thermosetting material is mostly within thethermoplastic body, extending only slightly outside of the thermoplasticbody and only on one end.) Silicone does not generally adhere tothermoplastic. However, a thermosetting material is desirable for thebiasing section 60 because it needs to be resilient, and, moreimportantly, not “cold flow”. Most thermoplastics, includingthermoplastic elastomers, experience cold flow, meaning that theypermanently deform when left under pressure. If the biasing section weremade of a material that experienced cold flow, after a period of storagein an assembled state, the biasing member would no longer continue tourge the piston section 50, and valve member 54 in particular, into theinlet channel and against the sealing surface 30.

The wiper seal 52 also should maintain its shape over time.Thermoplastic elastomers that are currently commercially available wouldprovide the resiliency needed, but would undergo cold flow if theneedlefree access device 10 were assembled and placed in storageawaiting distribution and use. However, in the future thermoplasticelastomers may be developed which would not have a detrimental degree ofcold flow.

The top of the preferred piston is either flush with, or morepreferably, extends out of the inlet 22 of the housing so that it can beaseptically swabbed. The piston section 50 of the preferred embodimentalso provides a unique inlet flow path that is made possible because aresilient material is used. The top of the piston section has agenerally elliptical shape in its unconfined form and a wedged shapedopening 56 that is closed when the top of the piston section 50 isforced into the round inlet opening. When the piston member is forceddownwardly against the biasing force and out of the tapered inletchannel, the normally generally elliptically top portion with wedgedshaped opening 56 returns to its underformed shape as the syring tipforces it down out of the inlet channel to a point in the housing havinga wider cross section. The opening 56 extends radially from thelongitudinal centerline of the piston member. However, the opening 56does not interconnect with the hollow central portion 62 of the biasingsection. Thus, when the access device is accuated, the flow out of thesyring tip passes through the opening 56 and out to the side of thepiston member into an area of reduced diameter above the valve member 54portion of the piston section 50. From here it can pass down the helicalflow channel 64, through the openings 76 and out the central flowchannel 78.

Rather than have a wedge shaped opening 56, other opening shapes may beused. A V-shaped groove extending across the minor axis of theelliptical shape of the piston top will have the same ability to closeup when forced upwardly into the inlet channel, but spring back openwhen depressed, and allow fluid flow out both sides of the groove. Sucha V-shaped groove is shown in the embodiments of FIGS. 15-17.

As noted above, the access device 10 is preferably made by providing afirst part comprising the monolithically formed housing 20, providing asecond part comprising the combination outlet section, biasing sectionand piston section, and constructing the needlefree access device 10 bysecuring the second part within the first part. Preferably the housing20 is made of a thermoplastic material that allows the flange 74 on theoutlet section to be sonically welded into the recess 37 in the base ofthe housing 20. In this manner the access device can be assembled fromonly two parts. Thus, in the preferred embodiment of the invention,piston section 50, biasing section 60 and outlet section 70 areconnected together such that they can be handled as one piece whenassembled with the housing 20 to make the needlefree access device 10.Hence, the combination outlet, biasing and piston member exists as asingle part before the needlefree access device is assembled.

The preferred combination outlet, biasing and piston member 40, whichconstitutes one variety of a flow control member, is made by firstinjection molding thermoplastic material to form the outlet section 70.FIG. 22 shows a mold that can be used for this purpose. The mold has abase section 80 and a first top section 82. The central flow channel 78is formed by a center core pin 84. The core pin 84 has an extensionmaking it longer than needed, as will be explained later. The openings76 are formed by side action pins 86, as is well known in the art ofthermoplastic molding. Hot, molten thermoplastic material is injectedthrough port 88 to form the outlet section 70. After the outlet section70 has solidified, the first top mold section 82 is removed. However,the outlet section is not ejected from the mold base 80, nor is thecenter core pin 84 removed. Instead, a second top section mold is put inplace, as shown in FIG. 23. This second top mold section is made of twohalves, 90 and 92. Each mold half has an extension 94 that extends intoone of the openings 76 to keep it open during the subsequent overmoldingoperation. Mold half 90 includes a port 96 through which resilientmaterial is injected into the cavity. Mold half 92 includes a protrusion98 that is used to form the wedge shaped opening 56 in the pistonsection 50. The extended part of the center core pin 84 now forms thehollow central portion of the biasing section 60. The helical flowchannel is made by flights on the insides of the top mold halves (eitherchemically or by solidifying from a molten state) 90 and 92.

In the preferred embodiment, the outlet section 70 interlocks with thebiasing section 60. This can be either a chemical or physicalinterlocking. If the resilient material does not bond to thethermoplastic material, the junction between the outlet section 70 andbiasing section 60 can be designed so that the biasing section ismechanically interlocked to the outlet section 70. This is most easilydone by forming an undercut in the top of the outlet section 70 justabove the openings 76, as shown in FIG. 23A. However, first top mold 82may then need to be made of two parts. It is important that mold base 80be made of only one part so that there is no part line in the luer tapersection 72 of the outlet section 70.

As used herein and in the claims, the term “overmolding” is used torefer to a process in which a first part is placed in a mold tool suchthat at least a portion of the surface of that part is exposed withinthe cavity of the mold tool. Thereafter material is introduced into thecavity to form an overmolded part having the shape of the cavity. Thenew material is in intimate contact with the exposed surface of thefirst part within the cavity, and is thus overmolded onto the firstpart. The first part may be of a different or the same material as usedto make the overmolded part. The overmold material may form a chemicalor melt bond to the first part, but this is not always the case. As justdiscussed, the overmolded biasing section 60 may be mechanicallyinterlocked to the outlet section 70.

In the preferred embodiment of the invention, the outlet section 70 isnot removed from the mold base 80 until it has the biasing section 60and piston section 50 connected to it. In this manner the combinationpart can be handled as one piece during the assembly process. Thissimplifies the assembly, and hence reduces the cost of the needlefreeaccess device 10. In addition to overmolding, there are other ways toproduce such a connected part using in-press assembly, meaning assemblyof the combined part while still in the molding press. For example, thebiasing and piston section could be molded with a different mold thatdid not have the outlet section already in it. Both the outlet sectionstill in its base mold and the combined biasing and piston section stillheld by its mold could be brought together and joined, such as with aninterference fit between the parts. The parts only need to be securedtogether to the extent that they remain together until inserted into ahousing. The joint between the biasing section and outlet section neednot prevent leakage because any leakage would be inside the housing andflow into the same path that fluid will flow anyway.

The outlet section 70 will typically be molded from a thermoplasticinjected at a temperature of between about 300° F. and about 800° F.,and at a pressure of between about 500 psi and about 2000 psi. The moldbase 80 will typically be cooled so as to maintain a temperature ofbetween about 50° F. and about 300° F. when the thermoplastic materialis injected. The precise temperatures and pressures will depend on themold configuration and the thermoplastic used, as is well known in theart. The thermoplastic material will most likely be selected from thegroup consisting of polycarbonates, polysulfones, nylons and acrylics.When polysulfones are used, the injection temperature will typically bein the 700-800° F. range. Polycarbonates, which are presently preferred,are injected at a temperature of about 600° F. A particularly preferredthermoplastic is Lexan™ polycarbonate from GE Plastics.

The second top section mold halves 90 and 92 will typically be heated soas to cause the thermosetting material to cure. The themosettingmaterial is preferably silicone rubber, which is made by mixing asilicone part A with a silicone part B. This mixing will most typicallyoccur just before the material is injected into the cavity of the secondtop section mold. However, the materials may be premixed and storeduntil used as long as it is stored under conditions and for a durationthat do not cause it to solidify. The material will typically beinjected at a pressure of between about 100 psi and about 900 psi, andat a temperature of between about 50° F. and about 100° F. The secondtop mold section will preferably be heated to a temperature of betweenabout 250° F. and about 400° F. when the mixture is injected. Apreferred material is LIM607 from GE Silicone, a 70 durometer liquidinjection moldable material.

A simple manufacturing cell 300 that could be used to mold the flowcontrol member 40 on pilot scale is shown in FIG. 25. The cell has twomolding press stations 302 and 304, a holding station 306, and anoff-loading station 308. Several multicavity mold bases 310, 312 and 314are used, each identical and containing eight cavities of a design ofthe mold base section 80. At molding press station 302, thermoplastic isinjected into the cavities of mold base 310 to form eight separateoutlet sections 70. The mold top held in press station 302 has eightcavities of the top section 82. At the same time this operation occurs,mold base 312, which was previously in molding press section 302 and hadthe outlet sections 70 molded in it, is in molding press section 304,where thermosetting material is injected to form the biasing section 60and piston section 50. Of course molding press section 304 carries aneight cavity mold, each with the mold halves 90 and 92 operationaltherein. At the same time that the two molding operations are going onin molding press stations 302 and 304, finished flow control members 40are off-loaded at off-loading station 308 from mold base 314 whichpreviously went through both molding press sections 302 and 304.

At the end of one cycle, when molding press sections 302 and 304 areopen, the mold bases 310, 312 and 314 are moved in a counter clock-wisedirection. Mold base 310 is first moved to holding station 306. Moldbase 314 now empty, is moved from the off-loading station 308 to thefirst molding press section 302. Mold base 312 is moved from moldingpress section 304 to off-loading station 308. Then mold base 310 can bemoved from holding station 306 into the molding press section 304. Themolding and off-loading operations are then repeated, and the cyclecontinues. One operator stationed at position 316 moves the mold bases310, 312 and 314 to their next location, while a second operator atposition 318 off-loads the molded parts.

A preferred high-capacity manufacturing operation that may be used tomold the flow control member 40 uses a rotary turntable molding press400, such as a Krauss Maffei brand rotary press, modified to use liquidinject moldable material on one side, as shown in FIG. 24. The press 400has a rotating center section 410, a left platen 412 used to moldthermoplastic material and a right platen 414 used to mold thermosettingmaterial. Platen 414 stays fixed, but center section 410 and left platen412 are moveable along linear guiding rails on the machine bed. Doubleacting hydraulic cylinders 416 or other types of mechanical devicesreciprocate to move the platen 412 and center section 410 from an openposition as shown to a closed position in which the moveable portionsare shifted to the right to close up the molds carried on the platensand center section 410. These cylinders also supply the needed clamppressure for the injection molding operations. The center section 410can be designed to carry either two or four multicavity mold bases 420,each cavity having the shape of mold base section 80 without injectionport 88. Platen 412 carries the first mold top 424 with cavities of theshape of top section 82, modified to include a port to inject thethermoplastic. Platen 414 carries the second mold top 426 with cavitiesin the shape of mold halves 90 and 92. The center section 410 slides ona bed, and has means (not shown) to slide it back to the center positionafter a molding step.

A thermoplastic injection system 428 is connected to and travels withplaten 412, so as to be able to inject molten thermoplastic through hotrunners in the mold top 424. The thermoplastic injection system 428 isconventional in design, with a heated barrel and a screw with flights tocreate the necessary injection pressure. On the right, stationary side,the press 400 holds two tanks 430 and 432 which hold the two siliconepart A and silicone part B, respectively. Metering pumps draw the liquidfrom the tanks and feed it through hoses 434 and 436 into a screwcylinder 438 where the two liquids are mixed. The screw cylinder alsobuilds the pressure to inject the silicone through runners in a coldplate formed as part of second mold top 426. However, the rest of themold top 426 is heated to provide conditions that will cure the siliconeonce it is mixed and injected.

The center section 410 includes energy circuits that allow the moldbases 420 to be cooled. For example, the mold bases may be left at about40-60° F. The energy circuits also actuate moveable portions within themold bases 420. Water is also used to cool the first mold top 424, tokeep it at a temperature of about 100-130° F. The second mold top 426 isheld a temperature of about 350-375° F.

The center section 410 includes a rotary table, to allow the centersection to rotate between its various positions. If four mold bases 420are used, as shown in FIG. 24A, the mold bases rotates 90° at each stepbetween a first molding station, where the thermoplastic is injected toform outlet sections 70, to a cooling station, to the second moldingstation where the silicone is overmolded, and finally to the off-loadingstation where the finished parts are ejected from the mold base 420.

Alternatively, in the embodiment shown in FIG. 24A, the cooling stationcould also include a thermoplastic treatment station, such as a plasmatreatment operation, which may be used to improve the adherence of theresilient thermosetting material to the thermoplastic material of theoutlet section.

FIG. 24B shows another alternative arrangement where only two mold bases420 are in place on center section 440. In this embodiment, the firstmolding and cooling operations both occur while the first mold base 420is in the first station. Meanwhile, the second molding with silicone,followed by off-loading, is occurring with the second mold base 420 inthe second position. The center section 440 is rotated 180° between eachoperation.

FIG. 24C shows yet another embodiment where all four molding stationsare used on center section 446. In this embodiment, the silicon ismolded onto the outlet section to form the flow control member at thesecond station. At the third station, the housing is assembled to theflow control member while it is still held in the mold base 420. Thisin-mold assembly requires the housings to be brought to the third moldstation in a way that they can be assembled in an automated fashion withthe flow control members. This may be done by leaving the housings inthe mold base in which they were formed and bring the entire mold baseand housings to the third station, preferably with a robot arm. Ofcourse the spacing of the housings in their mold base would have tomatch the spacing of the outlet sections in the mold base 420 for thisto work. Finally in the fourth station the entire needleless accessdevice is off-loaded.

A press assembly with more than four stations could also be used ifadditional steps, such as both cooling and plasma treating, and in-moldassembly with the housings, were all to be accomplished.

The needlefree access device of the present invention may be made withdifferent parts than those shown in FIGS. 1-8. For example, combinedbiasing and piston sections for a second embodiment of a flow controlmember are shown in FIG. 9. The biasing section 91 differs from biasingsection 60 in several respects, most significantly in that it is nothollow. Rather, the biasing section 91 has a solid central portion witha helical shape on its outer surface. However, the central portion isreduced in its average outside diameter so that the cross-sectional areaof solid resilient material is comparable to the cross-section ofmaterial in the biasing section 60 so that the biasing section 91 canstill collapse. The helical shape of its surface has a steeper pitchthan in biasing section 60. However, it cooperates with a housing (notshown) to define a helical flow path 95 when the valve member is open.The piston section 93 uses the same wedge shaped opening 97 as is usedin piston section 50. The combined biasing section 91 and piston section93 are preferably formed as one monolithic part, overmolded onto anoutlet section (not shown) that may have the same configuration asoutlet section 70. They are then inserted as a combined outlet, biasingand piston member into the housing just as with the access device 10. Asyringe tip can be pushed down to compress the biasing member 91 just asin FIG. 8A. The wedge shaped opening 97, which is closed when the piston93 is in a round inlet of a housing, then opens up to allow fluid totravel downwardly into the housing and out of opening 99.

A third embodiment of a needlefree access device 100 is shown in FIG.10. The needlefree access device 100 is also constructed from two parts.A housing 102 has a shape very similar to housing 20 of needlefreeaccess device 10, and the flow control member 104 is very similar to theflow control member 40. The primary difference is the shape of theopening 106 in the piston section. Whereas opening 56 was wedge shape,the opening 106 is more of a “U” shape that extends across the smalldiameter of the elliptical head. The opening 106 is closed when thebiasing section forces the piston section into the inlet channel of thehousing 102. However, as shown in FIG. 10, when a syringe tip 18 isinserted and depresses the top of the piston, the resiliency of thepiston causes the opening 106 to open up so that fluid can flow from thesyringe tip and out through the side of the piston section and follow ahelical flow path around the biasing section as in access device 10.

Just as with flow control member 40, the flow control member 104 has athermoplastic outlet section 108 with thermosetting material, such assilicone, overmolded to it to form the biasing section and pistonsection.

A fourth embodiment of a needlefree access device 130 is shown in FIGS.11 and 11A. The housing 132 used in this access device is similar tohousing 102, but includes a horizontal sealing surface 133. The pistonsection 138 and the biasing section 140 both include openings 142 formedsideways through the resilient material. These allow the biasing section140 to be compressed by a syringe tip forcing the piston section 138downwardly. In the embodiment of FIG. 11, the flow path is around theoutside of the biasing section as with the previously describedembodiments. However, the flow path does not have a helical shape.Rather flow channels 143 are formed in the side walls 144 of the housing132. These flow channels connect to a circumferential flow channel 145.Openings 146 are formed in the outlet section 148, similar to openings76 in outlet section 70. The openings 146 are adjacent to and in fluidcommunication with circumferential flow channel 145. Another feature ofneedlefree access device 130 is that it creates positive displacementwhen activated. In the embodiment of FIG. 11, the outlet section 148must be molded from a resilient thermoplastic in order for the portionof the mold tool that create voids 149 to be withdrawn after the outletsection is molded. In any event, again, the part can be made by a twoshot molding process like the other embodiments. The voids 149 are opento the atmosphere out the bottom of the access device. Thus, air can beforced out the bottom when the device is activated and flow back whenthe piston section returns to its position shown in FIG. 11. In thismanner, the closing of the piston does not draw fluid back up the outletsection 148 when valve closes.

As shown in FIG. 11A, the outlet section 148 is tied to the material 141surrounding voids 149 by webs 147. The openings 146 extend through thewebs 147 to provide fluid communication between the interior of thehousing 132, including channels 143 and 145, and the center flow path inoutlet section 148.

The needlefree access device 150 shown in FIG. 12 is much like theaccess device 130 except that the flow path through the body of theaccess device is through a helical groove 154 made in the side wall ofhousing 152, rather than the longitudinal flow paths 143 shown in FIG.11. The top section of housing 152 also includes some helical vents 157.These vents do not extend all the way to the top of the housing.However, they do extend to the shoulder that is used to make the sealingsurface inside the housing. The vents allow the piston section to closemost of the way without the wiper seal causing reflux. The vents aresmaller in their outer diameter than the top of the biasing section sothat the main seal can still be made.

The access device 170 shown in FIG. 13 is somewhat different in that thebiasing section 175 is molded as if it were two zigzag members 177 and178. Each is as thick as half the diameter, and as wide as the diameter,of the inside of the housing. The mold tool that forms this part hasmatting surfaces that contact each other over most of the longitudinalplane through a diameter of the access device. However, each of thesetool surfaces has a zigzag pattern cut into it, but the zigzags areopposite to one another. Thus when the tool closes up, the cornerportions of the cuts are opposite flat steel, while the central sectionsof the cuts intersect with one another. The resulting molded biasingsection thus has central areas in which the two zigzag pieces connect toone another. This design has a flow path that goes back and forth acrossthe width of the housing, through the spaces in between the members 177and 178, as it flows downwardly. Also, longitudinal flow path channels184 and circumferential flow channel 183 are provided in the side wallof the housing 186 so that fluid can flow into an opening 180 formed inthe outlet section 182. Again, this part can be molded in a two shotmolding process, where the outlet section 182 is molded first and thepiston section and biasing section 175 are overmolded onto it. FIG. 13shows a mechanical lock between the thermosetting material used to makethe biasing section 175 and the thermoplastic used to make the outletsection 182.

FIG. 14 shows how the needlefree access device of the present inventioncan be used as a bag port on an IV bag 200. The access device 210 hasnearly the same configuration as access device 10, except that the baseof the housing and outlet section are modified because they are sealedinto the IV bag and do not need to be connected to an IV line. As withother IV bags, a membrane seal 206 is provided on the bag, which may bepunctured with a spike 207. The bag can thus be stored for a long timein a sterile condition until it is punctured. The spike is sized to forman interference fit with the walls 208 of the port initially sealed bymembrane 206. The spike is then used to withdraw fluid from the IV bag.The access device 210 provides a port where a drug can be injected intothe fluid within the bag 210.

The access device 210 can also be used in a large volume drug containerwhich may be in the form of a bag that may contain hundreds of doses ofdrug. The needlefree access device 210 is then used as an access port towithdraw a single dose from the large volume container. The accessdevice 210 may also be used as an access port on a diluent container,such as a bag that contains a saline solution.

In this regard, it should be appreciated that other embodiments of theaccess devices of the present invention could also be used as an IV bagport. It should also be noted that the needleless access device of thepresent invention can be used for other purposes, such as a vialadapter, to allow fluid to be aspirated from a vial without the use of aneedle. Of course the internal components of the access device can alsobe used to make Y shaped access devices (see FIGS. 28 and 29) by using ahousing having another inlet.

A variety of flow control members that can be used to make otherembodiments of needlefree access devices of the present invention areshown in FIGS. 15-20. These flow control members can be assembled with ahousing such as housing 20 to make a needlefree access device, or can beused to make y-site needlefree access devices.

The flow control member 240 shown in FIG. 15 differs from flow controlmember 40 in three main ways. First, the opening 246 in piston section242 is V shaped, as opposed to wedge shaped. Second, the outside of thebiasing section 244 has a pointed configuration in the flights of thehelical path. Third, the inside surface of the hollow portion 248 is notsmooth, but rather also has a helical groove in it. This is thought tohelp the biasing section deform more uniformly when depressed. Thecenter core pin used to make the hollow portion 248 will still be ableto be withdrawn because of the resiliency of the material used to makebiasing section 244. Alternatively, it can be twisted out to follow thegeometry of the internal helix.

Flow control member 250, shown in FIG. 16, is similar to flow controlmember 240, except the outside of biasing section 254 does not have apointed configuration. However, it still provides a helical flow path.

Flow control member 260, shown in FIG. 17, has a thin-walled biasingsection 264, with a helical pattern both on the inside and outside, suchthat the thickness of the wall of the biasing section is generallyuniform.

FIG. 18 shows a flow control member 270 that is different in that it hasa flow path through the piston section. An opening 276 in the pistonsection 272 interconnects with the central hollow section 278 in thebiasing section 274. The piston section 272 may have an elliptical topsection, with the opening 276 being closed until the piston section 272is depressed to a point within a housing having a larger diameter, atwhich point it can open so that flow can go through the piston section.

Flow control member 280, shown in FIG. 19, is similar to flow controlmember 270 in having an opening 286 providing a flow path through thepiston 282. However, the hollow central section 288 is formed in anundulating pattern to match the outside of the biasing section 284, thuscreating a “bellows” design that can collapse as the piston 282 isdepressed.

FIG. 20 shows another embodiment of a flow control member 290 that isdesigned to collapse in a different manner since the biasing section 294has holes axially through its center, as well as recesses 298 in itssides. The piston section 292 can have a wedge shaped opening, or theentire piston section can cock to one side as it is depressed and thebiasing section buckles unevenly. In either event, the flow of fluidthen goes around the outside of biasing section 294 until it can enteropenings 297. The housing used with flow control member 290 willpreferably have an internal threaded section such as section 35 inaccess device 10 (FIG. 5).

Another two shot flow control member with quite a different design isused in needlefree access device 320 shown in FIG. 21. In thisembodiment, the biasing section and piston section are combined in asingle preslit septum valve 324. The housing 330 has a top section 331that includes an annular ridge 332.

An inlet member 340 includes outside threads 344 to form a luer lock,and an inside shape that allows it to fit against the annular ridge 332.The inlet member 340 also includes an internal flange 346 to help securethe valve 324 to the inlet member 340. The inlet member 340 is moldedfirst out of a thermoplastic material. The preslit septum valve 324 isovermolded inside of the inlet member, using a resilient material. Thevalve 324 has a slit 326 made in it either as part of the moldingoperation or afterwards. The combined pre-slit septum valve and inletmember is then sonically welded to the top 331 of the housing 330 tomake the access device 320. The inlet member 340 preferably has a luertaper surface on its inside, which allows for a luer slip connectionwith a syringe tip. When the syringe tip is inserted into access device320, the septum opens and the valve deforms inwardly, but is preventedfrom coming apart from the inlet member 340 because section 328 iscaptured between the inlet member 340 and the top 331 of the housing330.

Another embodiment of a needlefree access device 350 is shown in FIGS.26 and 27. This access device 350 uses a flow control member with abiasing section 360 which is solid in its center section and has ahelical shape, much like the combined biasing and piston sections shownin FIG. 9. The housing 370 can be configured just like housing 20. Theoutlet section 372 and openings 376 are just like outlet sections 70 andopenings 76, respectively. The helical shape of the biasing sectioncreates a helical flow path 374 within the housing.

The piston section or member 352 is similar to piston section 92, inthat it has a wedged shape opening 356 in the top of the piston member.In addition, however, the piston member 352 further includes a radialflow channel 358 cored out beneath the wedge shaped opening 356. Asshown in FIG. 26, the flow channel 358 is wider in its cross-sectionthan the opening 356 in the top of the piston member 352. Thus, evenwhen the piston member 352 is forced into a round inlet channel in thehousing 370, which causes the wedge shaped opening 356 to close, theflow channel 358 underneath is still partly open. As seen in FIG. 27,the wedge shaped opening 356 extends radially to one side of the pistonmember from a point which is between the centerline of the piston memberand the opposite side of the piston member. The flow channel 358 extendsfrom an even more distant point to the outside of the piston member 352.This flow channel 358 has been found to improve flow through the accessdevice 350 when a syringe tip depresses the piston and biasing sections.

Two Y-site needlefree access devices 380 and 390 are shown in FIGS. 28and 29, respectively. Both access devices are very similar, and use thesame biasing and piston sections as in access device 350. The two accessdevices differ in the piece in which the secondary inlet is provided. Inaccess device 380 a secondary inlet 382 is formed in the housing 384.The outlet section 386, biasing section 385 and piston section 383 areformed by a two shot molding process. The secondary inlet 382 is formedin a separate leg of the housing 384 than that which is used to housethe biasing and piston sections. The housing 384 may be molded as onemonolithic part with two legs, as shown, or it may be made fromdifferent parts that are then welded together. The housing 384 andoutlet section 386 may be connected together with solvent welding orother well known techniques.

The access device 390 has the secondary inlet 392 formed in the outletsection 386. The housing 394 is just the same as housing 20. The outletsection 386 is sonically welded to housing 394 just as housing 20 andoutlet section 70 are welded together.

The wedge shaped openings 387 and 397 in the top of the respectivepiston sections 383 and 393 are shown closed in FIGS. 28 and 29.However, the flow channels 389 and 399 underneath the openings stillhave a hollow section as shown because they are wider in cross-sectionthan the wedge shaped opening, and therefore do not close up all the waywhen the elliptical piston section is forced into the inlet of thehousing.

Another embodiment of a needleless access device 450 is shown in FIGS.30, 30A, 31 and 32. The access device 450 is similar to the accessdevice 350, in that it uses a solid biasing section with a helical shapeon its outer surface. However, there are several significant differencesbetween access devices 350 and 450. First, the number of revolutions orflights 465 on the helix is reduced, preferably to about 2.5revolutions, and each flight is thinned out. The preferred thickness ofeach flight is different. As shown in FIG. 30A, the top flight is thethickest, at about 0.06 inches. The second flight is about 0.05 inchesthick, and the third flight is about 0.040 inches thick. The thicknessof the flights and other aspects of the helical shape are used tobalance the spring force to get a good return while providing a goodflow rate through the device. Second, the central area of the biasingsection 460 was redesigned to increase its spring force by addingreverse cones 467 in its center between the flights 465. Third, the areaabove the wiper seal on the piston section 452 has a taper 451 (bestseen FIG. 30A) that makes it easier for the piston section to reenterthe inlet channel 473 of the housing 470 after the access device hasbeen opened by a luer tip. Fourth, the intersection between the biasingsection and the piston section, where the seal 454 is formed, wasmodified to be thicker, reducing the height of the piston section. Theinside of the housing 470 at this point is also larger in diameter thanhousing 70, and does not have the tapered section as in previousembodiments, so that the inside of the housing matches the largerdiameter of the top of the biasing section. Of course the housing 470still has to be designed with a slight draft, less than ¼ of a degree,to make it so the part can be easily removed from the mold tool.

The outlet section 472 is also modified. As best seen in FIG. 32, theundercut 477 is increased, and the top 479 is made solid. The length ofthe sides 471 is longer, making the height of the shoulder 475 aboveflange 474 shorter. This increases the surface area of the contactbetween the resilient material making up the biasing section 460 and thethermoplastic material making up the outlet section 472. Holes 463 onboth sides of the base of biasing section 460 are slightly larger thanthe holes 476 (best seen in FIG. 30) on both sides of outlet section472. These holes allow flow into the center of outlet section 472. Themold tool that forms the perimeter of holes 463 can close off againstthe thermoplastic surrounding the holes 476 during the over molding ofbiasing section 460. The housing does not need a threaded section likethe threaded section 35 in the housing 20. Rather, the base of thebiasing section is flattened on the sides that mate up with holes 476 inthe outlet section. After the helical flow around the piston section,the flow can split and go down either flat side into openings 463 and476.

As best seen in FIG. 31, the piston section 452 may be formed with aflat 453 opposite the wedge shaped opening 456 and cored out flowchannel 458. This flat is positioned at the beginning of the firstflight of the helix. Once the piston section 452 is pushed down, theflat 453, the inside of the housing 470 and the position of first flightcooperate to form a flow path right into the beginning of the helicalpath between the flights 465. This helps to reduce the potential for theformation of a bubble at this point. In some earlier piston designs, abubble would form at this point an not be flushed down the flow path.

While the preferred method of making the product is to use a two shotmolding of the biasing section 460 onto the outlet section 472, thedesign of the needleless access device 450 can also be made byseparately molding the biasing section 460 and the outlet section 472and joining them together in a separate operation. While some of thebenefits of the two shot, two piece product are not applicable to thismethod, the product can be made with conventional molding equipment,without the necessity of integrating thermoplastic and thermosettingmolding technologies. Thus, the very functional needleless access device450, having many desirable attributes, can be made even withconventional methods.

In the design of the access device 450 it has been found that the pitchof the helix, which is the linear distance from one crest to the next,will have an influence on the flow rate through the device. Currently apitch of 0.25 inches has been found to work the best. The thickness ofthe flights is also important. Preferably the pitch and thickness of theflights cooperate to form a flow path within the housing and around thehelix which is 0.04 inches wide.

Many of the desired attributes of a needleless access device arecompeting, making the optimal design difficult to achieve. For example,it would be nice to have a very resilient biasing section to provide agood return action, but this also increases the force required to openthe device. Also, if a low durometer silicon is used to make the biasingsection, a piston section made with the same low durometer silicon wouldtend to deform and occlude the syringe tip.

One possible solution to this problem is to cast the biasing and pistonsection in a two step molding process, where a stiffer (such as 80durometer) thermosetting material is used to form the head and a softer(such as 30 durometer) thermosetting material is used to form thehelical biasing section.

The design of the housing 470 and the flange 474 and shoulder 475 can bemodified so that instead of using ultrasonic welding to connect thehousing to the outlet section, a snap assembly could be used. Thethermosetting material could then be molded so as to include a sectionthat provides a gasket to help seal the needleless access device. Thesnap connection would preferably be able to withstand forces generatedby an internal pressure of 500 psi.

Another difficulty encountered with some designs is that the biasingsection is unable to return the piston section. A fine layer of oil orgrease applied to the flights on the piston section can help to overcomefriction between the flights and the wall of the housing. However, ifthe device is kept in use for a long time, or repeatedly actuated, thegrease can be washed away. It may be beneficial to mold the pistonsection from a thermosetting material that is self lubricating, such asliquid silicone elastomer CSM-4970-3 from NuSil Technology, Carpinteria,Calf. 93013. Another possible solution to this problem is to provide asurface modification on the housing and/or piston section. While siliconhas a high coefficient of friction on smooth thermoplastic surfaces,etching of the surfaces, or texturing the molds so as to produce atextured surface, could reduce the friction. However, one of thebenefits of the helical flow path on the outside of the biasing sectionis that the user has visual access through a clear housing to see theflow path. Any etching or texturing of the inside of the housing wouldtend to make it more difficult to see through the housing. Thus it wouldbe preferable to treat the silicone to reduce its friction. Such atreatment could include a sprayed on, baked coating available from GESilicone Division of General Electric.

Several modifications to the shape of the piston section to increaseflow rate are contemplated, as shown in FIGS. 33, 34 and 35. Each ofthese designs have the same biasing section 460 and sealing surface 454as used in the embodiment of FIG. 30. However, in piston head 462 (FIG.33), the relief 461 directly below the wiper seal has been added to makeit easier for the wedge shaped opening 466 to close when the pistonreturns from being actuated. The depth of the flow channel 468 can alsobe modified to prevent collapse and improve flow. In the piston head482, shown in FIG. 34, the area 485 at the base of the piston head isreduced in diameter. In the piston head 492 shown in FIG. 35, the wedgeshaped opening 496 goes almost across the entire diameter of the topsurface of the piston head.

In the embodiment of FIG. 36, the needleless access device 500 is verysimilar to the embodiment of FIG. 30. The main difference is the lengthof the housing 510 and the pitch of the helix. It was thought that ifthe pitch of the helix were increased, and the housing length was alsoincreased, flow rates through the device might be improved. However,testing of a device like that shown in FIG. 36, but with a short housingas in FIG. 30 and with a pitch of 0.358 inches, did not result inincreased flow rates.

A different pitch for a helix is shown on the combined piston sectionand biasing section 520 shown in FIG. 37. In this design, only onerevolution of the helix is used over the entire length of the biasingsection. The center 522 of the biasing section is a fairly thick column.

Another modified design is the combined biasing section and pistonsection 530 shown in FIG. 38. In this embodiment, the helix only hasone-half of a revolution, and the center section 532 is conical in shapeat the bottom. A slightly different embodiment, again with a half helix,is shown in FIGS. 39-41. The difference in this embodiment is that thebottom of the combined biasing section and piston section 540 isdesigned to sit on a separately formed outlet section 542, rather thanbe overmolded to it. In fact, in this embodiment the combined biasingand piston sections 540 need not be preassembled with the outlet section542 when the needleless access device 550 is assembled. Instead, thecombined sections 540 may be placed into the housing 544 and then theoutlet section 542 secured to seal the base of the housing.

It is preferable with this design to have quite a significant preloadingof the biasing section during the assembly. As seen in FIG. 40, thecenter column 546 deforms into a part helical shape itself when it iscompressed into the housing 544. When the piston section 548 is forcedinto the housing 544 by syringe tip 18 (FIG. 41), the center column 546further forms into a helix. Thus a helical flow path can be created evenwhen the biasing section does not have a helical shape over its entirelength.

FIG. 42 shows another embodiment of a combined piston and biasingsection 560. While this design does not use a helical shape, nor form ahelical flow path when placed inside a housing, it does use a pistonsection 562 with a wedge shaped opening 564 and a cored out flow channel566 underneath just like the piston section 452 of FIG. 30. The flowpath when the combined biasing and piston section 560 is used is overthe accordion shape folds of the piston section. This design is lesspreferred because it does not create a single flow path, like thatcreated with helical shape biasing sections. The biasing section can besolid or hollow, depending on the stiffness of the material of which itis made.

FIG. 43 shows a needleless access device 570 that is quite differentfrom other embodiments shown previously, but can be made using the twoshot molding method of the present invention. The needleless accessdevice 570 is patterned after a device shown in U.S. Pat. No. 6,651,956,which is hereby incorporated by reference. The needleless access device570 is a slit-type swabable luer-activated valve, but can be assembledfrom only two parts utilizing the present invention. Housing 572 can bemolded as one part. Outlet section 574 can be molded from athermoplastic in a first step, and overmolded with a thermosettingmaterial 576 in a second step. The top portion of the thermosettingmaterial 576 forms a piston that fits inside of the inlet section ofhousing 570. A slit 578 is provided in this piston section. The slit isnormally closed. A hollow chamber 575 is formed in the thermosettingmaterial 576 and extends into outlet section 574. When a syringe tip isforced against the thermosetting material 576, the material is forceddownwardly and then expands outwardly, filling housing 572. The slit 578opens so that fluid can be transferred through hollow chamber 575.

A variety of piston head designs are possible for use on needlelessaccess devices of the present invention. FIGS. 44A-44F show severaldifferent embodiments, each with an elliptical shape in its uncompressedstate and one or more openings to the side wall of the piston head. Inpiston head 580 (FIG. 44A), the wedge shaped opening 582 does not cometo a point, but rather has a radius. As shown in FIG. 44B, piston head584 has a wedge shaped opening 586. This embodiment differs in that thecored out flow channel 588 under the opening is deeper and the samewidth as the opening 586. FIG. 44C shows a piston head 590 that has awedge shaped opening 592 that extends about ¾ of the way across thediameter of the head. FIG. 44D shows a piston head 594 with six openings596, three on each side. The piston head 598 of FIG. 44E has two wedgeshaped openings 600, one on each side of the piston head. FIG. 44F showsa piston head 602 with an opening 604 which is a reverse wedge, i.e.,the opening is of a greater width in the center than at the perimeter.

Some of these designs may not be suitable if a syringe tip used with thepiston head has a small central bore opening. For example, piston heads594 and 598 could occlude the opening of a small bore syringe tip.Therefore products using these piston heads should specify the use ofstandard luer openings for mating connectors.

FIG. 45 shows a design for two mold halves 610, 612 to make the combinedbiasing and piston sections 460 and 452. The mold halves 610, 612 arecut to form cavities with the various features of the biasing and pistonsections, such as the helical shapes to form the flights 465. Alsoprotrusions 613 on mold half 612 form the wedge shaped opening 456 andcored out flow channel 458 in the piston section 452. A runner system614 is used to feed the thermosetting material into the mold cavity whenthe two mold halves are closed on another. As noted earlier, lands 616and 618 can close off against the sides of outlet section 472 around theholes 476 (FIG. 32) to form the holes 463. These holes allow flow fromthe outside helical flow path to enter the outlet section 472.

Because the surface 454 needs to form a good seal, it is preferable thatit be formed as one continuous surface, without a part line that wouldnormally be formed during an injection molding operation. For thisreason, the mold halves 610, 612 are designed to form that section ofthe piston head without a part line. This is accomplished by using aninsert 620 in mold half 610. The inside surface 622 of insert 620 formsthe sealing surface 454. A cut 624 is made in the other mold half 612for the insert 620 to fit into when the two mold halves are closed.

After the combined piston and biasing section is molded and cured, themold halves are opened. The part will remain in mold half 610,surrounded by insert 620. The part has to be pulled downwardly throughthe hole 622 to be de-molded. Since the part is made of flexible,thermosetting material, it can deform slightly so that the ellipticalshape of the top of the piston can fit through the hole 622.

FIG. 46 schematically shown additional features about the mold tool thatcan be used to make the combined outlet, biasing and piston member usedin the needleless access device 450. Mold halves 610 and 612 are used inthe process. FIG. 46 shows that the detail, such as protrusions 613which form the piston section, may be machined onto the insert 620 and asecond insert 621 while the inserts are separated from the mold halvesand thus more easily accessible. The inserts are shown in an explodedrelationship in FIG. 46. However, after the inserts are machined, theyare locked into place in mold tool halves 610 and 612 throughout furthermolding operations.

FIG. 46 shows the mold tools 628 and 630 and center core pin 632 thatare used to first mold the outlet section 472. When this section ismolded, there will be different mold tools (not shown) that will formthe top of the outlet section, including the undercut 477, the top 479,the sides 471 and the holes 476. After the outlet section 472 is molded,it remains on the center core pin 632. Mold halves 628 and 630 arereused, and the mold halves used to form the top of the outlet sectionare replaced by mold halves 610 and 612, with the inserts 620 and 621locked into place. The housing 470 is not present at this stage of theoperation. The mold halves 628 and 630 are closed (or remain closed) andthe mold halves 610 and 612 are closed. Silicone is injected into thecavity and the combined biasing and piston section 460, 452 isovermolded on the top of the outlet section 472, as shown. Mold half 612is pulled back to the position shown in FIG. 46, and mold halves 628 and630 are also opened. Center core pin 632 is then pulled downwardly topull the piston section 452 through the hole 622 in insert 620.Thereafter the mold half 610 can also be pulled back to the positionshown in FIG. 46.

At this point the center core pin can be raised back up and a housing470 can be brought into place by robot arm 634. Once the pieces arealigned, the combined outlet, biasing and piston section are insertedinto housing 470 and either snap assembled or welded together to formneedleless access device 450.

The present invention also includes positive displacement needlelessaccess devices. Needleless access device 130, shown in FIGS. 11 and 11A,has a positive displacement when activated, preventing the reflux offluid when the piston section returns to its closed position. Threeadditional positive displacement needleless access devices, or partsthereof, are shown in FIGS. 47-51.

Positive displacement needleless access device 640 is shown in FIG. 47.In this embodiment, the biasing section is hollow, and is formed withnumber of accordion ribs 644. A chamber 646 is formed inside the deviceby a separate part 670. Two of the accordion ribs 648 are wider than theothers and reach out far enough to contact the inside walls of thechamber 646. A vent 650 leads out of the chamber 646 and vents into thearea of the luer-lock threads inside the base of housing 652. As thepiston head 654 is activated, the biasing section 642 accordion folds,and ribs 648 force air out through the vent 650. When the piston isreleased, the biasing section 642 forces the piston back up into theinlet section of housing 652, and air can return through vent 650 intothe bottom of chamber 646. The piston head 654 includes a wiper seal656. However, rather than a wedge shaped opening into the side of thepiston head, the piston head has a flattened V shaped top surface. Theinlet of housing 652 has several flow channel 658 formed in itssidewall. Thus fluid can flow over the top of the piston head once thepiston head is depressed past the tops of the flow channels 658. Flowcontinues downwardly around the outside walls of part 670 formingchamber 646 and then radially inwardly through channel 672 into theinterior of outlet section 674. The outlet section 674 can be moldedfrom the same resilient material as is used to form the biasing section642 and piston head 654, or more preferably the part can be molded froma thermoplastic and the biasing section overmolded from a resilientthermosetting material. Unfortunately, it would be too difficult to alsomold the part 670 which forms the chamber 646 with the other biasingsection 642. Thus even though this design can utilize two-shot aspectsof the invention, it would still require three separate pieces to beassembled.

A flow control member 680 used to make another positive displacementneedleless access device is shown in FIG. 48. This part is molded from aresilient material as one monolithic piece. It can be inserted into ahousing like housing 652 to create a needlefree access device. Mold toolcore elements create voids 682 in the part 680 when it is molded and thecore elements are withdrawn, much like the voids 149 in the device 130of FIG. 11. Outlet channel 684 is molded using a transverse core pin.Also, cavity 683 extends completely through the part, like the openings142 in FIG. 11. Once the part is assembled in the housing, the fluidflow path is around the outside of the part and then inwardly throughchannel 684 to the interior of the outlet section 686. However, when thepiston section is depressed, the voids 682 can collapse, allowing air toflow to the exterior of the device through the area of the luer-lock,just as in access device 640. When the piston is released, air cantravel back in to fill the voids 682. These voids thus allow the pistonto return without causing reflux through the outlet section. The cavity683 fills with fluid, since it is open to the outside of the member. Asmall bridge 685 of material is designed to help prevent the outletchannel 684 from collapsing when the device is actuated. This bridge isformed by a gap between the pointed top of the core pin (not shown) usedto form the opening in the center of outlet section 686 and the bottomof the side slides (not shown) in the mold tool that create cavity 683.

Positive displacement needleless access device 690 is shown in FIGS.49-51. This device is made from three separate parts, a housing 692,flexible biasing and piston member 694 and a base outlet section 696.The biasing and piston member 694 is placed on top of base outletsection 696, and this combination is then inserted into housing 692. Thebiasing and piston member 694 includes an elliptical top shape with awedge shaped opening 698, just like the piston section 97 of pistonsection 93 shown in FIG. 9. Inside of the biasing and piston member 694is an air chamber 700, which is vented to the outside through fourchannels 702 found in base 696, best seen in FIG. 49. The top side ofthe base outlet section 696 includes a relief 697 cut into it (see FIG.50) that connects the four vent channels 702. This relief prevents thebiasing and piston member 694 from blocking the vent channels 702 whenit collapses. One or more flow channels 704 are cut in the side wall ofhousing 692 (see FIGS. 49 and 51). When the piston section is pusheddown by syringe tip 18 to the point shown in FIG. 51, the chamber 700collapses, with air flowing out of channels 702. Flow from the syringecan then pass through opening 698 into channel 704. Base 696 alsoincludes a transverse flow channel 706. Thus fluid can travel from flowchannel 704 into channel 706 and out through outlet 708. When thesyringe tip is withdrawn, biasing section 694 pushes the piston headback into the inlet channel of housing 692. Air can return to fill thechamber 700 through the channels 702.

Another form of a needless access device 710 is shown in FIG. 52. Thisdevice is like the Y-site devices 380 and 390 in that the housing 712has two inlets 714, 716 and one outlet 718. In this embodiment, flow cancontinue through the device from inlet 714 to outlet 718 regardless ofthe position of biasing and piston member 720. However, inlet 716 isdesigned like the top part of access device 450, in that the pistonsection 722 normally seals the inlet, but can be opened by insertion ofa syringe tip to give access to inlet 716. The biasing section 724 ismade with a helical design, creating a helical flow channel within thebranch of the housing containing the biasing section 720.

This embodiment can be made with two shot molding and two pieceassembly. The first part of the housing can be made with an opening intowhich a second part of the housing 726 fits to complete the housing.This second part of the housing can be molded first from a thermoplasticmaterial, and then the biasing and piston member 720 overmolded onto it.The overmolded part is then inserted into the first part of the housingand either snap assembled or ultrasonically welded to complete thedevice 710. In this embodiment, the part of the housing to which thethermosetting material is overmolded does not form an outlet to thehousing.

As noted above, in addition to needleless access devices, aspects of thepresent invention are also applicable to check valves. Two embodimentsof check valves are shown in FIGS. 53 and 54.

A first embodiment of a check valve 801 is schematically shown in FIG.53. The check valve 801 has three main elements, namely, a first housingpart 802, a second housing part 804 and a diaphragm 806 constituting asealing member positioned between these two housing parts. The diaphragmconstitutes a flow control member. Each of the housing parts includes aconnector, and is made by injection molding a thermoplastic material.Housing part 802 is designed as a hose connector, but also includes afemale luer taper 842 in its inlet 840. Housing part 804 includes anoutlet 821 in the form of a male luer-lock fitting 822.

The first housing part 802 includes an annular sealing surface 808against which the diaphragm 806 is pretensioned. The check valve 801 isespecially suitable for medical fluids, but could be used in otherfields, such as in the fields of micro pneumatics and micro hydraulics.

The diaphragm 806 can be lifted from the sealing surface 808 withsufficient overpressure in entry space 810 of the first housing part802, thus creating a flow path through the device. With an overpressurein an exit space 812 of the second housing part 804, the diaphragm 806safely and in minimal time can be pressed against the sealing surface808 for closing the check valve 801.

As shown in FIG. 53, the diaphragm 806 is connected with the secondhousing part 804 in a way that the second housing part 804, togetherwith the diaphragm 806, can be handled as a unit when being assembledwith the first housing part 802.

Preferably the diaphragm 806 is overmolded to the second housing part804 by the overmolding of a sealing member 816, of which the diaphragm806 is an integral part. The sealing member projects into the exit space812 of the first housing part 802 in such a way that the diaphragm 806is pretensioned against the sealing surface 808.

The diaphragm 806 preferably comprises a thermosetting material,preferably silicon, or a thermoplastic elastomer.

In the preferred embodiment shown in FIG. 53, the first housing part 802includes a skirt 818 reaching far downwardly which almost completelysurrounds the second housing part 804. As a result, the sealing surface808 is completely protected and deeply positioned within the firsthousing part 802.

As shown in FIG. 53, the second housing part 804 has a T-shapecross-section, wherein the upright member 820 of the T is formed as amale luer-lock-connector 822. The skirt 818 has an interior thread for apossible nut connection. The cross member 824 of the T-shaped secondhousing part 804 forms a wall connected with the interior side of theskirt 818 in a fluid-tight manner.

On the top side 828 of that wall a basically cylindrical body 830 ismonolithically formed with the rest of the second housing part 804. Thecylindrical body 30 contains a channel 832 for fluid to flow out of theoutlet 821. The sealing member 816 has a cup-shaped bottom section 834which is overmolded around the cylindrical body 30. A stem-shapedextension 836 connects the monolithic disk-shaped diaphragm 806 with thecup-shaped bottom section.

In case the pressure in the exit space 812 should become larger than inthe entry space 810, then the pressure of the fluid against thediaphragm 806 will keep the diaphragm 806 engaged against the annularsealing surface 808, preventing any reflux. This happens, too, if thefluid flow at the entrance 840 stops.

In addition to normally closed check valves, the present invention isapplicable to check valves wherein the sealing member, while still beingadjacent the sealing surface, is not necessarily pretensioned. The checkvalve would still close if fluid tried to flow backwards through thedevice.

The check valve 802 can be made by a two shot molding process. Thehousing part 802 is injection molded from a thermoplastic material,preferably chosen from the group consisting of polycarbonates,polysulfones, nylons and acrylic resins. The first housing part havingthe annular sealing surface 808 in the inlet space 810 either is ejectedfrom the mold after the solidification or is retained in the open moldin case an assembly within the injection molding machine is planned. Thesecond housing part 804 is also injection molded from a suitablethermoplastic material in a second injection mold, wherein the mold hasa bottom part and a first top part. The first top part molds the bypasschannels 832. Once it is removed, with the second housing part 804remaining in the bottom part of the mold, a second top part of the moldis positioned on the bottom part of the mold. The second top part of themold has a mold cavity corresponding to the diaphragm 806, the bottomsection 834 and the extension 836. Thereafter the elastic material isinjected into the second mold with the second top part thereon.

The unit produced thereby, consisting of the second housing part 804 anddiaphragm 806, can thereafter either be ejected from the second mold andthereafter assembled with the first housing part, e.g. by ultrasonicwelding, or by suitable measures an assembly within the injectionmolding machine can follow by bringing the bottom part of the firstinjection mold, still containing the first housing part 802, togetherwith the bottom part of the second injection mold, which still containsthe unit consisting of the diaphragm 806 and the second housing part804. Suitable ejector pins advance the second housing part 804 togetherwith the diaphragm 806 into the space surrounded by the skirt 818 untilthe wall reaches a step of the skirt 818 and is assembled with the firsthousing part 802 in a fluid tight manner, such as by ultrasonic welding.

One of the benefits of the check valve 801 is that it can be assembledfrom merely two parts. Further, a final assembly within the injectionmolding machine is possible.

A second embodiment of a check valve 831 is shown in FIG. 54. This checkvalve is very similar to the needleless access device 710 with respectto the housing, and uses very similar parts as check valve 801 withrespect to the diaphragm 806 and sealing surface 808.

The check valve 831 also has an injection molded housing made of twoparts, each made of suitable thermoplastic material. It has two inlets846 and 848 and one outlet 850. The inlet 846 is positioned coaxial tothe outlet 850. The second inlet 848 basically is normal to the commonaxis of the inlet 846 and the outlet 850.

The inlet 848 is controlled by the check valve generally designated with844. The connection between the first inlet 846 and the outlet 850 andthe second inlet 848 is by means of a common valve chamber 854. Thevalve chamber 854 is closed by a cover 856 (which constitutes a secondhousing part) of a thermoplastic material positioned opposite to thesecond inlet 848.

The check valve includes an annular sealing surface 809 surrounding thesecond inlet 848 against which a diaphragm 807 of resilient material ispretensioned.

According to the basic principle of the invention, the diaphragm 807 isconnected with the cover 856 in such a way that the cover 856 and thediaphragm 807 can be handled as a unit when being assembled with thehousing to form the check valve 831.

As with the first embodiment according to FIG. 53, the diaphragm 807 isconnected with the cover 856 by overmolding. In this embodiment, theresilient thermosetting material has a stepped cylindrical shape,matching that of the cover member 856, and also forms the diaphragm 807.

The check valve 831 is formed with a male luer-lock-connector for outlet850. The first inlet 846 is formed as a female luer-lock-connector suchthat the check valve 831 can be coupled with one or more check valves ofthe same kind in a row. Thereby a through-line can be formed having anumber of inlets 848 each controlled by a check valve 844 without acomplicated housing and the corresponding costs for the mold to makesuch a housing.

The check valve 831 is produced by first forming the T-shaped housing byinjection molding a thermoplastic material in a first mold. After thesolidification of the thermoplastic material, the finished housingeither is ejected from the mold or can be retained in the injectionmolding machine in one of the mold halves in a suitable position forfinal assembly. In a second split injection mold consisting of a bottompart and first top part, the cover 856 with the cylindrical projectionsis molded from a thermoplastic material and thereafter the first toppart of the mold is removed, wherein the cover 856 with the cylindricalprojections remains in the bottom part of the mold. Thereafter a secondtop part of the mold is positioned on the bottom part of the mold, thesecond top part of the mold having a mold cavity corresponding to thediaphragm 809, the bottom sections and the extension. An elasticmaterial, such as a thermo-setting material like silicon, or athermoplastic elastomer, is injected into the mold.

After the solidification, either the unit consisting of the cover 856and the diaphragm 807 can be ejected from the bottom part and can beassembled with the housing, or as with the embodiment of FIG. 53 a finalassembly can take place within the injection molding machine by keepingthe unit consisting of the diaphragm 807 and the cover 856 in the bottompart of the second mold and bringing it together with the housingremaining in the mold half of the first mold and directly assemblingthese parts by ultrasonic welding.

In addition to the fact that the preferred access device may beassembled from only two parts, and thus have a lower manufacturing cost,the access device can also be made with higher quality control becauseof its fewer parts. Some of the functional requirements that are met bythe preferred embodiments of the invention are as follows. In additionto being low cost because of the two part construction, the preferredaccess devices have an internal priming volume of less than 0.3 ml, morepreferably less than 0.1 ml. After a flush procedure using 1.5 ml ofsaline solution, the residual fluid in the access device should be lessthan 10% of the priming volume, preferably less than 2% of the primingvolume. The preferred access devices have a flow rate, measured at 39″water head pressure, of greater than 100 ml/min., more preferablygreater than 140 ml/min. The access devices can preferably be activatedat least 100 times, and more preferably at least 200 times, and retaintheir ability to reseal. In this manner one access device can be used ona patient that may need a large number of injections each day forseveral days.

The preferred access devices can withstand an internal pressure of atleast 100 psi, and more preferably at least 300 psi, and a negativepressure of at least 12.5 psi and more preferably at least 14 psi. Thewiper seal on the preferred connection will be able to prevent bacterialingress for at least 24 hours, and more preferably at least 96 hours.Preferably the top wiper seal, in addition to preventing bacterialingress, can withstand a pressure of 2 psi. The preferred access deviceswill have luer tapers on both the male and female connections, and becompatible with components that meet ISO 594-2 and ISO 494-2 standards,meaning that the access device male and female connections have the samediameter and 6% taper angle, but not necessarily the same length, as theISO standards. However, they will preferably still provide contact overat least 0.1 inches of length, but not necessarily the 0.25 inch lengthcontact of a standard luer taper. The preferred access devices are luerslip as well as luer lock compatible.

The amount of biasing force provided by the biasing member willpreferably be at least 0.2 lbs, and more preferably at least 0.5 lbs,but will produce an activation force of less than 3.5 lbs, and morepreferably less than 2.5 lbs. The preferred access devices have lessthan 30% flow reduction, and preferably less than 10% flow reduction,after 100 activations. The preferred access devices have a return timeof less than 1 second, more preferably less than 0.5 seconds.

The preferred access devices will be made from materials that arecompatible with a full range of fluids and antiseptics that are likelyto come in contact with the access devices, such as high dextrosefluids, blood plasma, lipid emulsions, taxol and other chemotherapydrugs, and providone iodine, chlorhexidine and isopropyl alcoholantiseptics. The access devices will also preferably be compatible withvarious other medical devices, such as IV pumps, as well as gravityinfusion, vacuum containers, jet injectors, IV sets and can withstandMRI fields. The preferred access devices can be sterilized by electronbeam, steam, gamma radiation and ethyl oxide gas.

As will be appreciated, making a device such as the preferred embodimentof the invention that meets all of the above requirements, can be madewith higher quality control, and can still be made at a low cost, is aconsiderable achievement. In addition, the preferred device is small,less than 1.3 inches, and preferably less than 1 inch in length.

It should be appreciated that the apparatus and methods of the presentinvention are capable of being incorporated in the form of a variety ofembodiments, only a few of which have been illustrated and describedabove. For example, the central portion of the biasing section 60 couldhave a small diameter central hollow area, have a different pitch in thehelical groove, be longer or shorter, etc. Also, rather than using asonic or solvent weld to connect the housing with the flow controlmember, a snap-lock feature could be used. The invention may be embodiedin other forms without departing from its spirit or essentialcharacteristics. The described embodiments are to be considered in allrespects only as illustrative and not restrictive, and the scope of theinvention is, therefore, indicated by the appended claims rather than bythe foregoing description. All changes that come within the meaning andrange of equivalency of the claims are to be embraced within theirscope.

1. A fluid handling device having a housing, a sealing surface and aflow control member comprising a flexible material biased against saidsealing surface, characterized in that the flow control member isovermolded onto a constructive member of the fluid handling device suchthat they can be handled as one unit when being assembled with thehousing to produce the fluid handling device.
 2. The fluid handlingdevice of claim 1 wherein the device is suitable for transferringmedical fluids.
 3. The fluid handling device of claim 1 wherein thefluid handling device comprises a needlefree access device.
 4. A fluidhandling device comprising: a) a housing having an inlet and an outletand comprising a first housing part and a second housing part; b) asealing surface inside the housing; and c) a sealing member comprising aflexible material biased against the sealing surface; d) wherein thefirst and second housing parts are produced from thermoplastic material,and the sealing member and the second housing part are molded togethersuch that they can be handled as one unit when being assembled with thefirst housing part to produce the fluid handling device.
 5. The fluidhandling device of claim 4 wherein the device is suitable for handlingmedical fluids.
 6. The fluid handling device of claim 4 wherein thefirst housing part comprises said inlet and the second housing partcomprises said outlet.
 7. The fluid handling device of claim 4 whereinthe fluid handling device comprises a check valve.
 8. The fluid handlingdevice of claim 4 wherein the fluid handling device comprises a lueractivated valve.
 9. A method of making a fluid handling devicecomprising: a) forming a first housing part from a thermoplasticmaterial, the first housing part having a sealing surface; b) forming asecond housing part from a thermoplastic material; c) forming a sealingmember comprising a flexible material by overmolding the sealing memberto the second housing part such that the second housing member andsealing member can be handled as one unit when being assembled with thefirst housing part; and d) connecting the first housing member andsecond housing member together, with the sealing member biased againstthe sealing surface, to form the fluid handling device.
 10. The methodof claim 9 wherein the flexible material comprises a thermosettingmaterial.
 11. The method of claim 9 wherein the first and the secondhousing members are connected by ultrasonic welding.
 12. A fluidhandling device according to claim 1, characterized in that the fluidhandling device is a needlefree access device.
 13. A needlefree accessdevice comprising: a) a housing having an inlet and an inlet channel;and b) a combination outlet, biasing and piston member having i) apiston section moveable between a closed position in which the pistonsection is in the inlet channel and an open position in which the pistonsection is inside the housing below the inlet channel but allows fluidto flow through the inlet channel, ii) a biasing section connected tothe piston section that normally biases the piston section into theinlet channel; and iii) an outlet section interlocked to the biasingsection and having an outlet fitting in fluid communication with theinside of the housing; wherein the piston section, biasing section andoutlet section are connected together such that they can be handled asone piece when assembled with the housing to make the needlefree accessdevice.
 14. The needlefree access device of claim 13 wherein the inletchannel comprises a female luer taper.
 15. The needlefree access deviceof claim 13 wherein the piston section in its closed position seals theinlet channel against airborne bacteria.
 16. The needlefree accessdevice of claim 13 wherein the combination outlet, biasing and pistonmember comprises thermoplastic material and resilient material.
 17. Theneedlefree access device of claim 16 wherein the resilient material isovermolded onto the thermoplastic material.
 18. The needlefree accessdevice of claim 13 wherein the piston section in its closed position iseither flush with or extends out of the housing inlet.
 19. Theneedlefree access device of claim 13 wherein the biasing section is madefrom resilient material.
 20. The needlefree access device of claim 19wherein the resilient material of the biasing section has a Shore Adurometer of between about 30 and
 90. 21. The needlefree access deviceof claim 13 wherein the biasing section has a solid central section. 22.The needlefree access device of claim 16 wherein the resilient materialis a resilient thermosetting material.
 23. The needlefree access deviceof claim 13 wherein the biasing section is generally hollow.
 24. Theneedlefree access device of claim 13 wherein the biasing section has ahelical flow channel around its center portion.
 25. The needlefreeaccess device of claim 24 wherein the helical flow channel has across-sectional width of about 0.02 inches when the piston section is inits open position
 26. The needlefree access device of claim 24 whereinthe helical flow channel has a cross-sectional width of about 0.04inches when the piston section is in its open position.
 27. Theneedlefree access device of claim 13 wherein the piston sectioncomprises a normally elliptical top portion with a wedge shaped openingtherein.
 28. The needlefree access device of claim 27 wherein thehousing inlet is round and the piston member is deformable such thatwhen the piston section is in its closed position, the top portion isforced into a round shape and the wedge shaped opening is closed. 29.The needlefree access device of claim 28 wherein the piston sectionfurther comprises a radial flow channel beneath the wedge shapedopening.
 30. The needlefree access device of claim 13 wherein thehousing comprises a generally smooth cylindrical wall surrounding thebiasing section.
 31. The needlefree access device of claim 30 whereinthe housing further comprises an internal threaded section adjacent theconnection between the biasing section and the outlet section.
 32. Theneedlefree access device of claim 13 wherein the outlet section forms aclosure to the housing, thus directing flow through the housing to passthrough the outlet fitting.
 33. The needlefree access device of claim 32wherein the outlet section has a flange sonically welded to a recesswithin the housing to form said closure.
 34. The needlefree accessdevice of claim 19 wherein the resilient material of the biasing sectionhas a Shore A durometer of between about 50 and about
 80. 35. Theneedlefree access device of claim 13 where in the piston sectionincludes a wiper seal.
 36. The needlefree access device of claim 13wherein the piston section and biasing section are formed as onemonolithic piece.
 37. The needlefree access device of claim 36 whereinthe monolithic piece is overmolded onto the outlet section to providethe combination outlet, biasing and piston member.
 38. A fluid handlingdevice comprising: a) a housing; and b) a flow control member, the flowcontrol member comprising thermoplastic material and resilientthermosetting material overmolded onto the thermoplastic material. 39.The fluid handling device of claim 38 wherein the flow control member ismade in a two-shot molding process.
 40. The fluid handling device ofclaim 38 comprising a needlefree access device.
 41. The needlefreeaccess device of claim 40 wherein the flow control member comprises apiston section, a biasing section and an outlet section, the piston andbiasing section being made from the resilient thermosetting material andthe outlet section being made from the thermoplastic material.
 42. Theneedlefree access device of claim 41 wherein the housing comprises aninlet channel and the biasing section normally biases the piston sectionto close the inlet channel.
 43. The needlefree access device of claim 42wherein the biasing section provides a force of between about 0.2 lbsand about 3.5 lbs.
 44. The fluid handling device of claim 38 comprisinga check valve and wherein the flow control member comprises a diaphragm.45. A flow control member for use in a fluid transfer device, the flowcontrol member comprising: a) a housing part formed of thermoplasticmaterial; and b) a sealing member overmolded onto the housing part. 46.The flow control member of claim 45 for use with a needlefree accessdevice wherein the flow control member comprises a combined biasingsection and piston section formed from resilient material, and thehousing part comprises an outlet section.
 47. The flow control member ofclaim 45 wherein the resilient material comprises thermosettingmaterial.
 48. The flow control member of claim 47 wherein thethermosetting material comprises silicone.
 49. The flow control memberof claim 45 wherein the resilient material comprises thermoplasticelastomer.
 50. The flow control member of claim 46 wherein the biasingsection has a solid central portion and is shaped in a helix.
 51. Theflow control member of claim 46 wherein the biasing section has acentral hollow portion and a helical flow channel formed in its outersurface.
 52. The flow control member of claim 46 wherein the pistonsection comprises a normally elliptical top portion with a wedge shapedopening therein.
 53. The flow control member of claim 46 wherein thepiston section comprises an opening in the top thereof; and a flowchannel beneath and connected to the opening and extending radially tothe outside of the piston section, the flow channel having across-sectional area larger than that of the opening in the top of thepiston.
 54. The flow control member of claim 46 wherein the pistonsection comprises a normally elliptical top portion with a V-shapedopening across a minor axis of the ellipse.
 55. The flow control memberof claim 46 wherein the outlet section is mechanical interlocked to thebiasing section.
 56. A needlefree access device comprising: a) a housinghaving a round inlet, a tapered inlet channel that narrows inwardly fromthe inlet, a main body portion and a base opposite the inlet; b) apiston member inside the housing; and c) a biasing member inside thehousing normally biasing the piston member to close the inlet; d)wherein the piston member comprises a resilient material with a tophaving a generally elliptical shape and an opening that is closed whenthe top of the piston is forced into said round inlet opening but whichallows flow through the opening to the outside of the piston member whenthe piston member is forced downwardly against the biasing force and outof the tapered inlet channel.
 57. The needlefree access device of claim56 wherein the opening in the piston member is wedge-shaped.
 58. Theneedlefree access device of claim 56 wherein the opening comprises anopening in the top surface of the piston member and a flow channelunderneath the opening in the top which is wider in cross-section thanthe opening in the top.
 59. The needlefree access device of claim 56wherein the biasing member comprises a resilient member formedmonolithically with the piston member.
 60. The needlefree access deviceof claim 59 wherein the biasing member has a hollow central portion, butthe opening in the piston does not interconnect with the hollow centralportion.
 61. The needlefree access device of claim 56 wherein the pistonmember includes a wiper seal capable of preventing airborn bacterialingress while the piston is in a closed position.
 62. The needlefreeaccess device of claim 45 wherein the wiper seal can also withstand apressure of at least 2 psi.
 63. The needlefree access device of claim 56wherein the piston has a top surface that extends above the inlet. 64.The needlefree access device of claim 63 wherein the top surface of thepiston member is slanted and expends above the inlet on only one side ofthe access device.
 65. The needlefree access device of claim 57 whereinthe wedge shaped opening extends radially to one side of the pistonmember from a point which is between the centerline of the piston memberand the opposite side of the piston member.
 66. A method of making aneedlefree access device comprising: a) forming a housing having aninlet and a base; b) forming a flow control member by i) moldingthermoplastic material to form an outlet member and ii) overmoldingresilient material onto the outlet member, the resilient materialforming a piston section and a biasing section; c) inserting the flowcontrol member into the housing such that the piston section is adjacentto the inlet; and d) securing the outlet member into the base of thehousing.
 67. The method of claim 66 wherein the outlet member issonically welded into the base of the housing.
 68. The method of claim66 wherein the thermoplastic material is injected in a molten state intoa mold having a base section and a first top section and allowed tosolidify.
 69. The method of claim 68 wherein after the thermoplasticmaterial is allowed to solidify, the first top section of the mold isremoved, the solidified thermoplastic material remains in the basesection of the mold and a second top section mold is placed over thebase section of the mold, the second top section having a cavity formolding the resilient material.
 70. The method of claim 69 wherein theresilient material is a silicone thermosetting material made by mixingsilicone part A and silicone part B together and injecting the mixtureinto the cavity in the second top section.
 71. The method of claim 70wherein the mixture is injected at a pressure of between about 100 psiand about 900 psi, and at a temperature of between about 50° F. andabout 100° F.
 72. The method of claim 68 wherein the thermoplasticmaterial is injected at a temperature of between about 300° F. and about800° F., and at a pressure of between about 500 psi and about 2000 psi.73. The method of claim 70 wherein the second top mold section is at atemperature of between about 250° F. and about 400° F. when the mixtureis injected.
 74. The method of claim 68 wherein the mold base section isat a temperature of between about 50° F. and about 300° F. when thethermoplastic material is injected.
 75. The method of claim 66 whereinthe thermoplastic material is selected from the group consisting ofpolycarbonates, polysulfones, nylons and acrylics.
 76. A method ofmaking a needlefree access device comprising: a) providing a first partcomprising a monolithically formed housing; b) providing a second partcomprising a combination outlet section, biasing section and pistonsection; c) constructing the needlefree access device by securing thesecond part within the first part, the access device being made onlyfrom the first and second parts.
 77. A needlefree access devicecomprising: a) a housing; and b) a flow control member, the flow controlmember comprising a thermoplastic outlet section and a resilientmaterial overmolded onto the thermoplastic material.
 78. The needlefreeaccess device of claim 77 wherein the housing includes threads for aluer lock fitting in the area surrounding the inlet channel.
 79. Theneedlefree access device of claim 77 wherein the housing comprises abase with threads for forming a luer lock.
 80. The needlefree accessdevice of claim 13 wherein the housing comprises an internal sealingsurface and the piston section seals against the sealing surface toprevent backflow through the access device when the piston section is inits closed position.
 81. The needlefree access device of claim 35wherein the wiper seal closes the inlet against airborn bacteria whenthe piston section is in the closed position.
 82. A needlefree accessdevice comprising: a) a housing having an inlet, a base, and a main bodyportion having a generally cylindrical inside surface between the inletand the base; b) a valve member actuatable between an open position anda closed position, wherein in the closed position the valve memberprevents flow between the inlet and the outlet; c) a central body withinthe main body portion of the housing, the central body having a helicalshape on its outer surface, the central body fitting against the insideof the cylindrical surface when the valve member is in its openposition; d) the helical shape defining a helical flow path through themain body portion of the housing when the valve member is in an openposition.
 83. The needlefree access device of claim 82 wherein thehousing further comprises a tapered inlet channel having a luer taperfor engaging with a syringe tip having a luer taper.
 84. The needlefreeaccess device of claim 82 wherein the valve member is formed as part ofa piston section of a combined piston section and biasing section. 85.The needlefree access device of claim 84 wherein the central body formspart of the biasing section.
 86. The needlefree access device of claim84 wherein the combined piston and biasing section comprises resilientmaterial and is overmolded onto an outlet section comprisingthermoplastic material, which in turn is attached to the base of thehousing.
 87. The flow control member of claim 46 wherein the top portionof the piston has a V-shaped opening therein.
 88. The needlefree accessdevice of claim 59 wherein the biasing member has a solid centralportion.
 89. The needlefree access device of claim 13 wherein theneedlefree access device is in the form of a Y-shape access device, andcomprises a secondary inlet.
 90. The needlefree access device of claim89 wherein the secondary inlet is formed in the housing.
 91. Theneedlefree access device of claim 89 wherein the secondary inlet isformed in the outlet section.
 92. An IV bag having a port comprising aneedlefree access device as recited in claim
 13. 93. A needlefree accessdevice comprising: a) a housing having an inlet, an inlet channel and anoutlet; and b) a biasing and piston member having i) a piston sectionmoveable between a closed position in which the piston section is in theinlet channel and an open position in which the piston section is insidethe housing below the inlet channel but allows fluid to flow through theinlet channel; and ii) a biasing section connected to the piston sectionthat normally biases the piston section into the inlet channel, thebiasing section comprising a resilient body having a helical shape on atleast part of its outer surface.
 94. The needlefree access device ofclaim 93 wherein the helical shape comprises at least one completehelical revolution.
 95. The needlefree access device of claim 93 whereinthe helical shape comprises less than one complete helical revolution.96. The needlefree access device of claim 93 wherein the housing is madeof a housing member and an outlet member secured to the housing memberand providing the outlet thereof.
 97. The needlefree access device ofclaim 96 wherein the outlet member comprises an outlet sectioninterlocked to the biasing section and having an outlet fitting in fluidcommunication with the inside of the housing; wherein the pistonsection, biasing section and outlet section are connected together suchthat they can be handled as one piece when assembled with the housing tomake the needlefree access device.
 98. A check valve having a first anda second housing part and a flexible sealing member positionedtherebetween, which is adjacent a sealing surface such that overpressurein an entry space of the first housing part causes the sealing member tobe lifted from the sealing surface, opening a flow path through thecheck valve, wherein the two housings parts are produced fromthermoplastic material by injection molding, and wherein the sealingmember and the second housing part are molded together such that theycan be handled as one unit when assembled with the first housing partfor producing the check valve.
 99. The check valve of claim 98 whereinthe sealing member is pretensioned against the sealing surface.
 100. Thecheck valve of claim 98 having a T-shaped housing with two inlets andone outlet, wherein the first inlet is positioned coaxially to theoutlet and the second inlet is controlled by the check valve.
 101. Thecheck valve of claim 98 wherein the connection between the first inletand the outlet is by way of a valve chamber which is closed by a coverpositioned opposite to the second inlet, the cover comprising the secondhousing part.
 102. The check valve of claim 98 wherein the sealingmember comprises a resilient thermosetting material.
 103. The checkvalve of claim 98 wherein the sealing member comprises silicon.
 104. Thecheck valve of claim 98 wherein the second housing part and connectedsealing member are formed by a two-shot injection molding process. 105.The check valve of claim 98 wherein the first housing part comprises afemale luer-lock-connector.
 106. The check of claim 98 wherein thesecond housing part comprises a male luer-lock-connector.
 107. A methodfor producing a check valve comprising the steps of: a) injectionmolding a housing part from a thermoplastic material having an inlet andan annular sealing surface within an entry space; b) injection molding asecond housing part from a thermoplastic material; c) overmolding anelastic material onto the second housing part, the elastic materialforming a sealing member; d) inserting the second housing part and thesealing member into the first housing part in such a way that thesealing member is pretensioned against the annular sealing surface; ande) connecting the first and the second housing parts.
 108. The method ofclaim 107 wherein the first and the second housing parts are connectedby ultrasonic welding.
 109. The method of claim 107 wherein the secondhousing part is not removed from the mold prior to the overmolding step,and at least part of the mold used in the overmolding step was used inthe step of injection molding the second housing part.
 110. A checkvalve comprising: a) a housing having an inlet and an outlet andcomprising, a first housing part and a second housing part; b) a sealingsurface inside the housing; and c) a sealing member comprising aflexible material adjacent the sealing surface; d) wherein the first andsecond housing parts are produced from a thermoplastic material byinjection molding, and the sealing member and the second housing partare molded together such that they can be handled as one unit when beingassembled with the first housing part for producing the check valve.111. The check valve of claim 110 having a T-shaped injection moldedhousing of thermoplastic material with two inlets and one outlet,wherein flow through the second inlet is controlled by the sealingmember, and wherein the connection between the first inlet and theoutlet is by way of a valve chamber which is closed by a coverpositioned opposite to the second inlet, the cover comprising saidsecond housing part and being connected together with the flexiblematerial.